EFPIA welcomes the adoption of the EMA Fees regulation by the Council and the Parliament. 

The revised EMA Fees Regulation will support and ensure the modernisation and sustainability of the regulatory system, allowing adaptability for emerging technologies that will address the future needs of healthcare systems across Europe. 

A robust well-resourced regulatory network is a key success factor in achieving Europe’s health and industrial strategy goals.  

To ensure success, it will be essential that the EU regulatory system expands its capacities and capabilities by recruiting technical expertise in cutting edge fields and retaining experienced talent.

Both the EMA and National agencies across the European Union must have the necessary resources – including appropriate funding, infrastructure and staff - to deliver their public health missions.

In some Member States, the current lack of resources puts unprecedented pressure on national and EU regulators, and in turn undermines national, local and European competitiveness – crucial enablers of innovation.

EFPIA supports a balance of simplification in fees administration while maintaining a proportionate cost-based approach and fair distribution among the fees based on the services provided.

EFPIA welcomes the fact  that elements such as relevant performance indicators and workload will be included in the EMA annual report. 

Nathalie Moll, Director General, EFPIA, said:  “The success of the pharmaceutical industry across the EU relies on a properly funded and structured EMA. The regulatory system needs to be globally competitive in terms of decision making timeliness and this Regulation should contribute to this.

The revised EMA Fees Regulation must also be supported with the appropriate revisions within the Pharmaceutical Legislation so that patients across Europe are able to benefit from new medicines as swiftly as those in other parts of the world.”

Mark Mayer, co-chair of the EFPIA Fees policy group and Assoc. VP, Global Regulatory Policy, Eli Lilly and Company, said: “Delivering for patients is at the heart of this new EMA Fees regulation. Enabling more resources for the EMA and the National Competent Authorities, is one step in improving the efficiency of the assessment of innovative medicines. Bringing stakeholders together, including industry, during EMA’s initial implementation and in future adjustments will be vital for realising this promise.”